Gen-Probe has reported that it plans to initiate a pivotal clinical study of its investigational PCA3 assay that could lead to regulatory approval by the FDA.
Gen-Probe’s clinical study is expected to begin in the third quarter of 2009 and take about a year to complete. The company anticipates it will involve more than 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.
According to Gen-Probe, recent study data suggest that the company’s investigational test for the highly specific prostate cancer gene PCA3 may help address some of the well-known challenges that urologists face when diagnosing prostate cancer, such as accurately identifying potentially aggressive cancers while minimizing ‘false positive’ results that can lead to overtreatment.
PCA3 is a gene that is highly over-expressed in more than 90% of prostate tumors, indicating that it may be a useful biomarker for prostate cancer. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen testing, the company said.
Henry Nordhoff, Gen-Probe’s chairman and CEO, said: Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PCA3 assay, when used in conjunction with other tests, can help predict the risk of a positive follow-up biopsy, thereby aiding in the diagnosis of prostate cancer. We are pleased to be moving ahead with a US clinical trial that could lead to improved patient care.